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Inventory & Production Management for Medical Equipment

The control
tower for your
medical device
production facility.

Biocompatible materials, sterile packaging, and FDA design controls across diagnostic, surgical, and implantable device lines. FalOrb gives medical equipment manufacturers real-time visibility into regulated materials, device BOMs, lot records, and compliance documentation.

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Real-Time StockDevice BOMLot TrackingMRP PlanningUDI ComplianceSterilisation TrackingSupplier ManagementAudit LedgerReal-Time StockDevice BOMLot TrackingMRP PlanningUDI ComplianceSterilisation TrackingSupplier ManagementAudit Ledger
Medical Equipment Manufacturing operations
01 / The Problem - Cleanroom Production
■ The Problem

Your medical device line
runs on
compliance documentation gaps.

Every component traceable to supplier lot. Every manufacturing step documented per device history record (DHR). Every finished device assigned a unique device identifier (UDI). When an FDA inspector requests the complete DHR for a specific device, you need every material lot, process step, and test result instantly. Not tomorrow. Not after lunch.

FalOrb was built for the regulatory demands of medical device manufacturing - where a DHR gap can trigger an FDA warning letter and a traceability failure can escalate to a Class I recall.

Pain 01
Device History Record Completeness
Every manufactured device requires a complete DHR linking materials, processes, personnel, and test results. DHR data collected across multiple systems. Assembly-level records disconnected from component-level lot traceability.
Pain 02
Biocompatibility and Material Control
Materials in contact with patients must meet biocompatibility requirements. Material substitutions require re-validation and potentially new 510(k) submissions. No system-level lock preventing unapproved material substitutions in production.
Pain 03
Sterilisation Batch Tracking
Devices sterilised in batches with specific parameters per sterilisation method. Sterilisation records linked to device serial numbers. No integrated system connecting production lot, sterilisation batch, and UDI assignment.
Pain 04
CAPA-Driven Inventory Actions
Corrective actions may require quarantine or recall of affected inventory. Affected lot identification relies on manual traceability. No automated scope assessment linking a CAPA to all potentially affected material lots and finished devices.
Medical Equipment Manufacturing production

Inventory & Production

Real-Time Stock / Multi-Level BOM / Auto-Costing

Supply chain operations

Supply Chain & Operations

MRP Horizons / Supplier Management / Alert System

Medical Equipment Manufacturing platform
02 / The Platform - Built for Medical Equipment Manufacturing
■ The Platform

One system from
raw material to
released medical device.

FalOrb covers the full medical device lifecycle. Regulated material inventory, device BOM management, DHR-ready production records, lot traceability, and UDI assignment - all connected in one FDA-ready platform.

Every material lot is tracked. Every process step is recorded. Every device is serialised. From incoming material inspection through cleanroom assembly, testing, sterilisation, and packaging to released and distributed medical devices.

■ Platform in Action

See what your
medical equipment manufacturing operations
look like inside FalOrb.

Real screens. Real layout. Simulated data from a medical equipment manufacturing facility.

01 / Overview

Operations Dashboard

One screen to see every location, every critical item, every in-transit shipment. Health status propagates from stock to location to the organization level.

falorb.com/overview

Overview

Updated just now
Refresh
7
Total Locations
3
Critical Items
8
Pending Transfers
15
Active Alerts
Manufacturing
18
Active Production Orders
2
Material Shortages
1
Products ATP Zero
5
MRP Shortfalls
Network
Cleanroom Assembly (ISO 7)
Production
Healthy
4 critical 18 low 412 healthy
Sterilization & Packaging
Production
Low
8 critical 24 low 287 healthy
Biocompatible Materials Vault
Warehouse
Critical
12 critical 35 low 198 healthy
MedTech Distribution Hub
Distribution
Healthy
9 low 523 healthy 37 surplus
02 / Production

Production Orders

Full lifecycle tracking from draft to completion. Material status tells you instantly whether the line can run or needs procurement action.

falorb.com/production-orders

Production Orders

+ New Order
All 18
Draft 2
Confirmed 3
In Progress 6
Completed 3
Order #ProductLocationQty OrderedQty ProducedMaterialStatus
PO-2026-1101Titanium Hip Implant (Cemented)Cleanroom Assembly (ISO 7)600425SufficientIn Progress
PO-2026-1102Digital X-Ray Detector PanelCleanroom Assembly (ISO 7)120120SufficientCompleted
PO-2026-1103Surgical Stapler (Disposable)Sterilization & Packaging15,0009,400PartialIn Progress
PO-2026-1104Patient Vital Signs MonitorCleanroom Assembly (ISO 7)2500CriticalConfirmed
PO-2026-1105PEEK Spinal Fusion CageCleanroom Assembly (ISO 7)2,0000SufficientDraft
03 / Alerts

13-Type Alert System

Auto-generated, role-routed alerts with one-click acknowledge and resolve. The system detects, you act.

falorb.com/alerts

Alerts

All 15
Active 8
Acknowledged 3
Resolved 1
TypeItemLocationMessageTriggeredStatus
▲Stock OutTi-6Al-4V ELI Titanium Bar StockBiocompatible Materials VaultZero stock — implant machining line halted10 min agoActive
▲Below Safety StockEtO Sterilization Gas CartridgesSterilization & PackagingStock at 14 cartridges below safety threshold of 501 hr agoActive
▼MRP ShortfallMedical-Grade PEEK Polymer RodsCleanroom Assembly (ISO 7)Projected shortfall of 200 rods in 3 weeks3 hrs agoPending
▼Regulatory HoldBiocompatible Silicone Tubing (USP Class VI)Biocompatible Materials VaultLot requires updated supplier CoC before release to production5 hrs agoPending
●Transfer CompleteSterile Tyvek Pouch (12x18")Sterilization & Packaging10,000 units received from MedTech Distribution Hub8 hrs agoResolved
Module 01
Location Management
Every plant, warehouse, and zone mapped. Multi-site hierarchy with role-based access control across your entire operation.
Module 02
Item & BOM
Multi-level bill of materials with auto-costing. Component tracking from raw input to final assembly with full version control.
Module 03
Production Orders
Material reservation, real-time progress, and variance tracking across every production run. Full lifecycle visibility from creation to completion.
Module 04
ATP Engine
Available-to-promise. Know what you can make and when, before committing to delivery. Real-time calculation against live stock and reservations.
Module 05
Transfer Engine
Structured inter-location transfers. Request, approve, ship, receive - every step recorded in the ledger with full chain of custody.
Module 06
MRP & Procurement
Demand planning across 7, 14, 30, and 60-day horizons. Purchase order lifecycle and supplier management with automated recommendations.
Module 07
Alert System
13 alert types with auto-resolve capability. Role-routed by severity to ensure the signal reaches the person who can act - immediately.
Module 08
Audit Ledger
Immutable. Every movement, every adjustment, every transaction recorded permanently. Nothing is mutated directly. The single source of truth.
■ How It Works

From stockout
to signal in
under a second.

When a critical material drops below threshold, FalOrb doesn't wait for someone to notice. The system detects, alerts, acts, and records - automatically.

01
Detect
Stock health reclassified in real-time. Four-state system flags the risk level before it becomes a problem.
02
Alert
The right role receives the alert. 13 alert types ensure the signal reaches the person who can act.
03
Act
Transfer request routed. MRP recommendation generated. Production order adjusted. Structured workflow, not ad hoc chat.
04
Record
Every action logged to the immutable audit ledger. Full traceability from detection to resolution.
“
Designed on the factory floor, not in a software lab. Every feature exists because a manufacturer needed it. Not because a product manager imagined it.
- FalOrb, Product Philosophy
8
Core Platform Modules
13
Alert Types / Auto-Resolve
60d
MRP Planning Horizon
4
Stock Health States

Your device production
deserves DHR-ready traceability.

FalOrb is built for medical device manufacturers where FDA compliance is the operating baseline, DHR completeness is mandatory, and lot traceability from material to patient determines your ability to maintain market access. If that's your facility, let us show you what connected medical device manufacturing looks like.

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